Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients (IOP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Orna Geyer, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01709916
First received: October 17, 2012
Last updated: November 4, 2012
Last verified: November 2012
  Purpose

Glaucoma is one of the leading causes of blindness in the west. The disease caused by high intra ocular pressure (IOP) and characterized by damage to the optic nerve and gradual loss of visual field. Intra ocular pressure change during the day. To evaluate the efficiency of the therapy it is common to measure the intra ocular pressure at different times of the day. Most ophthalmologists admit the patient for one day at which intra ocular pressure is measured at different times. This method does not mimic the patient daily routine and may not reflect the true diurnal fluctuations.

For this reason some ophthalmologists measure the intra ocular pressure at different times and at different days. It is not known if both methods give similar diurnal curves.


Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • IOP at different times of the day at same day versus different times and different days [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    measurements of intra ocular pressure at different times of the day at same day versus different times and different days.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Glaucoma patients
Glaucoma patients treated with eye drops to lower the IOP.

Detailed Description:

A study physician will install anesthetic eye drops and will color the eye drops film with fluorescein. Study physician will use tonometer to measure the intra ocular pressure in each eye. This is a standard procedure done in any ophthalmological examination. Each patient will undergo intraocular pressure examination at 8:00, 12:00 and 16:00.

In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day measurements. The day after intra ocular pressure will be measured at 8:00, two days after at 12:00 and three days after at 16:00. One month later the patient will undergo another serious of intra ocular pressure measurements.

In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day measurements. The day after intra ocular pressure will be measured at 8:00, two days after at 12:00 and three days after at 16:00.

The relationship between the two diurnal curves will be analyzed.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Glaucoma patients using eye drops to lower intra ocular pressure.

Criteria

Inclusion Criteria:

  • Glaucoma patient.
  • Age 18-80 years
  • Able to read and understand Hebrew, able to sign informed consent in Hebrew.

Exclusion Criteria:

  • Ophthalmic laser treatment or surgery 3 months prior to enrollment.
  • Eye infection or inflammation.
  • Corneal pathology altering IOP measurement.
  • Patients not cooperating during IOP measurement.
  • non compliant patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709916

Locations
Israel
Carmel Medical Center Not yet recruiting
Haifa, Israel, 34362
Contact: Orna Geyer, MD    972-4-8250419    orna_geyer@clalit.org.il   
Contact: Shaul Sar, MD    972-4-8250706    ShaulSa2@clalit.org.il   
Principal Investigator: Orna Geyer, MD         
Sub-Investigator: Shaul Sar, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Orna Geyer, MD Carmel Medical Center
  More Information

No publications provided

Responsible Party: Orna Geyer, Professor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01709916     History of Changes
Other Study ID Numbers: CMC-11-0037-CTIL
Study First Received: October 17, 2012
Last Updated: November 4, 2012
Health Authority: Israel: Clalit Health Services

Keywords provided by Carmel Medical Center:
Glaucoma
intra ocular pressure
diurnal fluctuations

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 23, 2014